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Revision History
Approvers
Owner Kelsey Mehlhorn Dept/Function Director of Quality
Approver Jon Gehm Dept/Function VP of Operations
Approver Carole Reed Dept/Function Director of Finance
Approver Vacant Dept/Function VP of Engineering
Approver Bob Abrams Dept/Function VP of Sales
Approver Lynn Reed Dept/Function President
Approver Dept/Function
Other
Distribution Documents
Company-wide N/A
List: Affected by
Change:
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Table of Contents
Revision History ......................................................................................................................... 1
Approvers .................................................................................................................................. 1
1.1 General .......................................................................................................................... 6
1.2 Purpose .............................................................................................................. 7
1.3 Applicability of ISO 9001/AS 9001 ...................................................................... 7
1.4 Mission ............................................................................................................... 7
1.5 Core Values: ....................................................................................................... 8
1.6 Strategic Direction............................................................................................... 8
1.7 Terms & Definitions ............................................................................................. 9
2.0 Responsibility ................................................................................................................11
3.0 Reference......................................................................................................................11
4.1 Context of the organization ............................................................................................11
4.2 Understanding the Organization and its Context ................................................11
4.3 Understanding the needs and expectations of Interested Parities ......................12
4.4 Determining the Scope of the Quality Management System...............................12
4.5 Quality Management System and Its Processes ................................................12
5.1 Leadership ....................................................................................................................15
5.2 Leadership and Commitment .............................................................................15
5.2.1 General ..................................................................................................15
5.2.2 Customer Focus ...................................................................................16
5.3 Quality Policy .....................................................................................................16
5.2.1 Tekmos has established the Quality Policy as: .......................................16
5.2.2 Communicating the Quality Policy ..........................................................16
5.3 Organizational Roles, Responsibilities and Authorities .......................................16
6.1 Planning ........................................................................................................................17
6.2 Actions to Address Risks and Opportunities .......................................................17
6.2.1 When planning for the QMS, Tekmos will consider the issues ................17
6.3 Quality Objectives and Planning to Achieve Them .............................................18
6.3.1 Quality Objectives ..................................................................................18
1.0 General
The design and implementation of the Tekmos’ QMS is influenced by the organizational
strategic direction, changes in that environment and the risks associated with that
environment, its varying needs, the particular objectives, the product it provides, the
processes it employs and its size and organizational structure. Tekmos promotes the
adoption of a process approach and risk-based thinking when it develops, implements
and improves the effectiveness of the QMS .
The model of our process approach for delivery of product can be seen in Figure 1
1.1 Purpose
Tekmos provides a coordinated and systematic approach for delivering quality
products on time. Tekmos has:
a. determined the processes needed for the quality management system
including their applications throughout the organization
b. determined the sequence and interaction of these processes
c. determined the criteria and methods needed to ensure that both the operation
and control of these processes are effective
e. ensured the availability of resources and information necessary to support the
operation and monitoring of these processes
f. measured, monitored and analyzed these processes
g. implemented actions needed to achieve planned results and continual
improvement of these process
Tekmos manages these processes in accordance with the requirements of ISO
9001:2015 and AS9100 Rev D, where processes that affect product conformity to
requirements are outsourced. The type and extent of control to be applied to
these processes is defined within the QMS.
1.3 Mission
1. Tekmos, Inc., headquartered in Austin, Texas, is a provider of ASICs,
microprocessors, and standard parts. Our corporate mission is:
1. Tekmos’ goal is to be the service and quality leader for the customers we
serve. Quality and reliability begins during design and/or development of our
products and continues throughout the product’s life cycle.
2. Quality is defined clearly, in measurable terms, beginning at executive levels,
and is disseminated to all Tekmos employees. Targets are set in focus areas
for continuous improvement with appropriate training to assure success.
3. Our supplier/partners are a key part of our quality process. Clear
expectations are set, measured, and achieved. Quality measurement and
achievement are formal factors in reviews, rewards, and recognition with our
suppliers/partners.
1.5 Strategic Direction
Markets- Focus on high reliability markets; Military, Aerospace, Medical,
Industrial, and Oil.
Capability-Increase mixed signal capability, and supporting newer
technologies.
Corporate- Position for acquisition.
Product- RISC V processor, High Temperature Peripherals.
A visual conception of our context of organization can be seen below.
Suspect Unapproved Part-A product that might not have been or is suspected of
not having been produced in accordance with applicable laws and regulations.
Work Transfer - The transfer of work which can include transfer from one
organization facility to another, from Tekmos to the supplier or from one supplier
to another supplier.
2.1 Responsibility
1. The primary responsibility of the QMS at Tekmos starts with the President and the
EQB. The EQB shall be responsible for assuring that the proposed processes and
procedures are implemented and adhered to at all levels of the organization.
Tekmos’ QMS operates to and in compliance with documentation contained or
referenced in this manual. Objective evidence (records) are obtainable from the
Document Control database, Design databases, Manufacturing database, and are
available for internal audits as well as customer audits.
3.0 Reference
ISO 9000:2015 Quality Management Systems-Fundamentals and vocabulary
AS9100: REV D Quality Management Systems- Requirements for Aviation, Space, and
Defense Organizations
a) determine the inputs required and the outputs expected from these
processes;
b) determine the sequence and interaction of these processes;
c) determine and apply the criteria and methods (including monitoring,
measurements and related performance indicators) needed to ensure
the effective operation and control of these processes
d) determine the resources needed for these processes and ensure their
availability;
e) assign the responsibilities and authorities for these processes;
f) address the risks and opportunities as determined in accordance with
the requirements of 6.1;
g) evaluate these processes and implement any changes needed to
ensure that these processes achieve their intended results;
h) improve the processes and the quality management system.
To the extent necessary, Tekmos will:
a) maintain documented information to support the operation of its
processes;
b) retain documented information to have confidence that the processes
are being carried out as planned.
The model in figure 2 depicts the interaction of processes within Tekmos to affect
the Continual Improvement of the QMS.
2. Sales
3. Engineering
6. Quality
1. Administration
5.0 Leadership
5.1 Leadership and Commitment
5.1.1 General
A. The management of Tekmos recognizes its role in assuring product and
service quality meet customer expectations and are compatible with the
context and strategic direction of our company . This role includes policy
development, training, QMS awareness, corporate measures, recognition,
resource allocation, and continuous improvement planning. Management
defines, documents, and implements an QMS reflecting the company's
quality goals. The Director of Quality assures the system is communicated
throughout the company through the operational and strategic planning
process.
B. The EQB has overall responsibility for the definition of and compliance to the
Quality Policy and quality objectives, which are published annually as part of
the Tekmos Strategic Plan. Tekmos’ management shall review the process
regularly (as defined in document control review procedures) for compliance
and progress.
C. Tekmos has developed and adopted a Quality System utilizing ISO
9001:2015 and AS 9100 Rev D as key building blocks. This system is
articulated in the QMS manual in terms of major components, expectations,
and results-oriented criteria. In turn, they define core processes, support
process flows and checklists to assure compliance.
D. Beyond the system-oriented processes, specific key objectives and results
are an integral part of the formal planning processes. These two components
make up the formal expectations for product and service quality objectives.
Tekmos utilizes a number of methods including operation plans, reviews,
executive staff meetings, and communication meetings to review measurable
performance criteria against expectations.
E. Leadership will engage, direct and support persons to contribute to the
effectiveness of the QMS, review for improvement and support other
Any action that affects the quality of Tekmos products or services is the
responsibility of every employee. This quality responsibility extends to include
our suppliers and/or subcontractors. Roles, and responsibilities and authorities
are defined, documented, and communicated in job descriptions and
organizational charts. The Director of Quality or an appointed designee shall be
Tekmos’ Management Representative and responsible for all questions or
comments regarding the QMS system at Tekmos and have the organizational
freedom and unrestricted access to top management to resolve quality issues.
6.0 Planning
6.1 Actions to Address Risks and Opportunities
6.1.1 When planning for the QMS, Tekmos will consider the issues
referred to in 4.1 and the requirements referred to in 4.2 and determine
the risks and opportunities that need to be addressed to:
a) give assurance that the quality management system can achieve its
intended result(s);
b) enhance desirable effects;
c) prevent, or reduce, undesired effects;
d) achieve improvement.
6.1.2 Tekmos will plan:
a) actions to address these risks and opportunities;
b) how to:
1) integrate and implement the actions into its quality
management system processes (see 4.4);
2) evaluate the effectiveness of these actions. Actions taken to
address risks and opportunities shall be proportionate to the
potential impact on the conformity of products and services. See
our risk register.
7.0 Support
7.1 Resources
Tekmos’ management is committed to providing adequate resources to attain the
quality goals. Adequate staffing, training, and yearly performance appraisals
assures and measures continuity throughout our processes. Internal quality
audits shall verify the effectiveness of Tekmos’ Operations and Engineering
7.1.1 General
Tekmos will determine and provide the resources needed for the
establishment, implementation, maintenance and continual improvement
of the quality management system.
Tekmos will consider:
a) the capabilities of, and constraints on, existing internal
resources;
b) what needs to be obtained from external providers.
7.1.2 People
Programs are developed as determined by each group to meet current
and near term needs. Training covers all aspects of administrative,
professional, environmental controls and aspects and technical activities
as deemed necessary by each employee’s manager.
Corporate training includes orientation and employee benefits. Career or
professional development training covers the background skills for career
development in each employee’s performance review. Records of this
competency are maintained. Employees are made aware through
training of the importance of conformity with our policy and procedures,
their roles and responsibilities and the consequence of noncompliance to
procedures. Quality manages this training and any company-wide
classes. Records and rosters for training will be maintained in employee
training records.
7.1.3 Infrastructure
The EQB provides and maintains the infrastructure needed to achieve
conformance to product requirements. This includes, buildings,
workspace, associated utilities, process equipment (hardware and
software) and supporting services (such as transport, communication, or
information systems).
7.2 Competence
Tekmos will:
a) determine the necessary competence of person(s) doing work under its
control that affects the performance and effectiveness of the quality
management system;
b) ensure that these persons are competent on the basis of appropriate
education, training, or experience;
c) where applicable, take actions to acquire the necessary competence,
and evaluate the effectiveness of the actions taken;
d) retain appropriate documented information as evidence of
competence.
To ensure competence of employees, job descriptions are prepared which
indicate appropriate education, training, and/or experience required to perform
the indicated tasks regardless of whether the task directly or indirectly affects
product quality. Employees shall be hired, and consultants engaged, on the
basis of their ability to meet these requirements. All staff has access to
necessary training to meet quality requirements
Managers are responsible for identifying general quality and skill requirements
for their assigned personnel. Job descriptions include quality requirements that
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are provided for all positions. Managers are responsible for developing job
descriptions and training requirements.
Tekmos provides personnel with orientation, training and continuing education as
needed to support competent job performance. All personnel must develop and
maintain competencies necessary to perform essential job duties. The
department managers must determine these skills updates and requirements.
Through coaching and team meetings, area managers ensure that all personnel
are aware of the relevance and importance of their activities and how they
contribute to the achievement of quality objectives. Training is conducted to
ensure competency is maintained via On-the-Job Training (OJT), special testing
and/or group training.
7.3 Awareness
Tekmos will ensure that persons doing work under the organization’s control are
aware of:
a. the quality policy;
b. relevant quality objectives;
c. their contribution to the effectiveness of the quality management
system, including the benefits of improved performance;
d. the implications of not conforming with the quality management
system requirements.
e. their contribution to product or service conformity, product safety
and importance of ethical behavior.
7.4 Communication
The EQB has established a procedure for internal and external
communication processes to assure the effectiveness of the QMS. The
procedure describes how communications from interested parties is
received, documented and response made.
Tier 1 Quality
Manual
Tier 2 Procedures
Records, Checklists
Tier 4
7.5.3 Records
Records include all reports and product specifications generated by
Operations and Engineering, all legal documents, agreements, Non-
Disclosure Agreements, Customer Contracts, or any other proprietary
documentation generated by Sales, Product Marketing. Records also
include all Human Resource documentation, Purchasing Purchase
Orders, and Finance invoices.
8.0 Operations
8.1 Operational planning and control
Tekmos will plan, implement and control the processes (see 4.4) needed to meet
the requirements for the provision of products and services, and to implement the
actions determined in Clause 6 by:
a) determining the requirements for the products and services;
b) establishing criteria for: the processes; the acceptance of products and
services. If customer accepts samples of product, they are evaluated as a low
risk evaluation
The output of this planning shall be suitable for the organization’s operations.
Tekmos will control planned changes and review the consequences of
unintended changes, taking action to mitigate any adverse effects, as necessary.
Tekmos will ensure that outsourced processes are controlled (see 8.4).
Project Management
As appropriate to the organization and the product, Tekmos will plan and
manage product realization in a structured and controlled manner to meet
requirements at acceptable risk, within resource and schedule constraints.
Spreadsheets for deliveries or white boards are used to prioritize work.
Blue Tekmos
Green Suppliers
Figure 3: Tekmos’ Product Development Flow Chart.
Tekmos will use representative items from production to verify that the
production processes, production documentation and tooling are capable
of producing parts and assemblies that meet requirements. This process
shall be repeated when changes occur that invalidate the original results
(e.g., engineering changes, manufacturing process changes, tooling
changes).Tekmos maintains procedures for inspection documentation
and first article inspection activities, when required. Tekmos Quality and
Engineering shall review manufacturing data to ensure process control
and stability during the incoming inspection.
8.5.2 Identification and Traceability
1. Identification and sequence of operations are traceable by suppliers
and Tekmos employees for all products during all stages of production
and test.
2. Each container of a purchased item is uniquely identified and is
traceable to the supplier, wafer fabrication facility, assembly location,
and the received date. Suppliers maintain identification, traceability,
and assurance for product and its location in the process.
3. Means of traceability include: Fab Process Run Cards, Assembly
Travelers, Test, QA, and Shipping Travelers, labels on boxes, and
permanent markings on material and/or product.
4. A specific identification numbers are assigned for traceability of a
product shipped to customer. Suppliers maintain all process records.
8.5.3 Customer property
Tekmos will exercise care with customer property while it is under our
control or use. Customer property will be tagged and a customer property
spreadsheet will be maintained to track, identify, protect and safeguard
the property. Customer notification will be given if the property is lost or
damaged.
8.5.4 Preservation
Procedures include, as necessary, provisions for:
a) Cleaning.
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used for packaging are specified and the packaging adequately protects
product during shipment. All products are clearly and properly identified.
Shipping documentation is prepared and verified by Tekmos or
designated subcontractors to be correct and legible prior to shipping.
Information on shipping containers matches that on shipping documents.
Quality periodically verifies the following by an audit of the
subcontractors/suppliers:
Clear and correct product identification on shipping documents
Appropriate shipping documentation
Adequate protection and labeling of product in shipping containers
Quality periodically audits packaging to ensure packing instructions
are followed.
8.5.5 Post-delivery activities
Tekmos will meet requirements for post-delivery activities associated with
the products and services (e.g. after delivery). In determining the extent of
post-delivery activities that are required, Tekmos will consider:
a) statutory and regulatory requirements;
b) the potential undesired consequences associated with its
products and services;
c) the nature, use and intended lifetime of its products and
services;
d) customer requirements;
e) customer feedback
f) collection and analysis of in service data
g) -not applicable
h) -not applicable
i) not applicable
When problems are detected after delivery, Tekmos will take appropriate
action including investigation and reporting
Statistical techniques are used to evaluate a process and its variation. Tekmos
suppliers shall apply controls appropriate to the activities. Statistical techniques
shall be employed for those activities where effective:
a) Process flows must be maintained and documented
b) Process capability studies must be initiated where required
c) Statistical controls should be applied where critical
d) Process must be maintained and “in control”
assessment, Quality shall review all the audit findings and issue
corrective actions to the corresponding group in accordance with written
audit procedures. Audit results are brought to the attention of personnel
responsible in the area audited. Department managers ensure timely
corrective action is taken on non-conformances found. Subsequent
audits shall include review of previous findings to verify effective
corrective action has been implemented. Audit results are reported to the
EQB and reviewed through management review as a measure of the
effectiveness of the QMS System.
9.3 Management Review
General
At least 2 times a year (calendar)Tekmos’ QMS will be reviewed to
ensure its continuing adequacy and effectiveness.
Review Input
a) Results of Audits (internal, compliance, customer)
b) Customer feedback and quality measures
c) Process Performance
d) Corrective Action
e) Actions from various Management Reviews
f) Changes that affect the QMS
g) Recommendations for Improvement
h) Performance to Quality Metrics
i) Interested parties review
j) Review customer demands, continuous improvement, and
preventive action programs
k) Review Quality Policy for continuing suitability, compliance with
requirements, and continual improvement
Review Output
a) Improvement of the effectiveness of the QMS
b) Improvement of product related to customer requirements
c) needed resources and
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d) risk identified
10.0 Improvement
10.1 General
Continual Improvement
The EQB shall strive to continually improve the effectiveness of the QMS
through use of the Quality Policy, Quality Objectives, Audit Results,
Analysis of Data (metrics), and Management Reviews. Continuous
improvement activities will be recorded during management review.
10.2 Nonconformity and Corrective Action
1. Corrective action programs are implemented and maintained within
Tekmos as continuous improvement tools to identify and correct non-
conformances in process or service operations. These programs
measure processes, and based on data collected, develop short-term
corrective actions and long-term corrective actions to correct
problems and preclude their recurrence.
2. Non-conformances are identified and resolved through:
Analysis of Nonconforming Product
Failure Analysis
Assessment Findings
Internal Corrective Action Process
Appendix A
Organizational Chart
Appendix B
Process Definition Charts
Appendix C
Quality Goals
1.0 Administrative
Employee Performance Evaluations (every July):
Goal: 100%
Employee Records: 25% of employee records reviewed/ quarter
Goal: 100% Accurate
Customer Satisfaction Yearly Survey Responses (every 3rd Quarter):
Goal: 15%
IT: # of days network has not had issues
Goal: 95%
2.0 Sales
Response time for inquires/ Quarter
Goal: 72 hours
# of Quote/ Quarter
Goal: 60 Quotes
3.0 Engineering
1st time yield : # of First Time Yield/ Quarter
Goal: 80%
ASIC Product and Services to Agreed Dates
Goal: 90%
4.0 Purchasing and Supply Chain
# of Supplier Nonconformances/ Quarter
Goal: 0
# of Supplier Late Deliveries/ Quarter
Goal: 0
5.0 Post Manufacturing
# of not met shipments/ quarter
Goal: < 7
Cycle time to Finished Goods:
Goal: 80% of Agreed Time
6.0 Quality
#of NCP RMA/Quarter
Goal: <2
CAR timeliness:
Goal: 60 Day Closure